Department of Health and Human Services September 2013 – Federal Register Recent Federal Regulation Documents

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR Part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

NIOSH gives notice as required by Department of Health and Human Services regulations of a decision to evaluate a petition to designate a class of employees from the Sandia National Laboratory- Livermore in Livermore, California to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for revision of the approved information collection assigned OMB control number 0945-0003 scheduled to expire on 12/31/2015. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting requirements for the collection ``Recommended Glossary and Educational Outreach to Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use.''

The Bureau of Health Professions (BHPr) is announcing a change to its Health Workforce Research Center cooperative agreement program. Funding Opportunity Announcement (FOA) HRSA-13-185, issued on November 26, 2012, announced HRSA's intent to fund Health Workforce Research Centers (HWRCs) focusing on research and technical assistance (TA). The FOA identified five broad areas of focus for research in HWRCs: Allied health, long-term care, behavioral health, oral health, and flexible use of workers to improve care delivery and efficiency. The concentration area, ``flexible use of workers to improve care delivery and efficiency,'' was further defined via published ``frequently asked questions'' as an area intended to address questions related to leveraging the existing health workforce to improve access to care, efficiency, and effectiveness in care delivery. Suggested topics for study included novel health care roles, team-based care (including the composition of teams and division of responsibilities across a team), professionals working at the top of their skills and training, and delegation. These proposed concentration areas were selected as areas of critical importance to health workforce policies and programs, as well as areas in which substantial expertise exists outside the government, indicating strong potential for public benefit. Applicants were asked to design a portfolio consisting of six research or TA projects, of which a subset would be selected for completion in the first budget period. Applicants were instructed to use their own judgment and expertise in designing a portfolio that would address timely, relevant, and important health workforce policy and planning questions. Though the FOA indicated the intent to fund only one cooperative agreement in each research focus area, the latitude given to applicants in designing their portfolios resulted in diverse interpretations of the concentration areas, particularly in the ``flexible use of workers'' category. For example, the top two ranked ``flexible use of workers'' HWRC (ranked at second and third in the research category) have distinct areas of focus. One focuses its portfolio on use of workers in community health centers, health IT, and telehealth. The other focuses primarily on primary care, including competencies for primary care teams, temporal shifts between primary and specialty practice over time, and flexibility in primary vs. specialty care service offerings. After further consideration, and in light of growing interest in promoting full and effective use of health workers, HRSA has concluded it is appropriate and consistent with the intent of the FOA to fund more than one cooperative agreement in a single area of concentration if the proposals cover research on distinct issues of importance. With this in mind, BHPr intends to fund two HWRCs in the concentration area ``flexible use of workers.'' This decision was made in light of the critical importance of defining new and emerging roles and models of the health workforce to meet the nation's changing health care needs. In addition, this allows BHPr to fund directly down the rank order list of applicants produced in the independent review process.

This Notice advises the public that the Indian Health Service (IHS) proposes the geographic boundaries of the Service Delivery Area (SDA) for the Tejon Indian Tribe. The Tribe's federal recognition was reaffirmed by the Assistant Secretary of Indian Affairs on December 30, 2011. The Tejon Indian Tribe's SDA is to be comprised of Kern County in the State of California. The county listed is designated administratively as the SDA, to function as a Contract Health Service Delivery Area (CHSDA), for the purpose of operating a Contract Health Service (CHS) program pursuant to the Indian Self-Determination and Education Assistant Act (ISDEAA), Public Law 93-638.

The Food and Drug Administration (FDA) is extending the comment period for the advance notice of proposed rulemaking (ANPRM) that appeared in the Federal Register of July 24, 2013 (78 FR 44484). In the ANPRM, FDA requested comments, including comments on FDA's preliminary evaluation, and data, research, or other information that may inform regulatory actions that FDA might take with respect to menthol in cigarettes. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

In accordance with the Federal Civil Penalties Inflation Adjustment Act of 1990, the Office for Civil Rights has determined that an adjustment to the maximum civil money penalty amount for violations of the confidentiality provisions of the Patient Safety and Quality Improvement Rule is not required at this time.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on June 19, 2013, Vol. 78, page 36788 and allowed 60-days for public comment. One public comment was received on June 21, 2013 requesting the data collection plans and instruments. This information was sent to the individual on June 24, 2013. Another comment was received on August 14, 2013. Data collection plans and instruments were sent to the requester on August 14, 2013. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.